Study to Describe Real World Drug Retention Rate of the Tocilizumab at One Year

NCT ID: NCT02608112

Last Updated: 2020-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

291 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2018-07-26

Brief Summary

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This multicenter, prospective, non-interventional study is designed to obtain an accurate estimation of the drug retention rate of Tocilizumab (TCZ) Subcutaneously (SC) under real-world conditions in participants with moderate to severe rheumatoid arthritis (RA).

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Moderate to Severe RA

Participants with moderate or severe RA, naïve to TCZ treatment (IV or SC), and who have no contra-indication to TCZ SC therapy as per the local label are included.

Methotrexate

Intervention Type DRUG

Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.

Tocilizumab

Intervention Type DRUG

Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.

Interventions

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Methotrexate

Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.

Intervention Type DRUG

Tocilizumab

Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants at least 18 years old
* Participants with moderate to severe RA not previously treated with TCZ (Intravenous \[IV\] or SC) for whom the rheumatologists have decided to initiate TCZ SC treatment as monotherapy or in combination with another conventional synthetic disease modifying anti-rheumatic drugs (csDMARD)

Exclusion Criteria

* Participants taking part in a clinical trial on RA at the time of inclusion
* Participants with a contra-indication to TCZ SC therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Hopital Nord; Rhumatologie

Amiens, , France

Site Status

Ch D Ardeche Meridionale; Medecine A2

Aubenas, , France

Site Status

Ch De Belfort; Rhumatologie

Belfort, , France

Site Status

Institut Calot Helio Marin; Rhumatologie

Berck, , France

Site Status

Hopital Jean Minjoz

Besançon, , France

Site Status

Hopital Pellegrin; Rhumatologie

Bordeaux, , France

Site Status

Hopital La Cavale Blanche; Rhumatologie

Brest, , France

Site Status

Hopital Cote De Nacre; Rhumatologie

Caen, , France

Site Status

CH Jean Rougier; Rhumato Reed Fonctionnelle

Cahors, , France

Site Status

Infirmerie Protestante; Medecine interne Cancerologie

Caluire-et-Cuire, , France

Site Status

Hopital Pierre Nouveau;Medecine C Unite Rhumatologie

Cannes, , France

Site Status

Cabinet medical,Rhumatologie

Castelnaudary, , France

Site Status

Hopital Trousseau; Rhumatologie

Chambray-lès-Tours, , France

Site Status

HIA PERCY; Medecine Interne

Clamart, , France

Site Status

Hopital Gabriel Montpied; Service de Rhumatologie

Clermont-Ferrand, , France

Site Status

CH compiègne

Compiègne, , France

Site Status

Centre Hospitalier Alpes

Contamine-sur-Arve, , France

Site Status

Chu Sud Francilien; Rhumatologie

Corbeil-essones, , France

Site Status

CH Sud Francilien; Rhumatologie

Corbeil-Essonnes, , France

Site Status

Hopital Henri Mondor; Rhumatologie

Créteil, , France

Site Status

CH de Dax

Dax, , France

Site Status

Ch De Douai; Medecine Polyvalente

Dechy, , France

Site Status

Ch Louis Pasteur; Rhumato Med Interne Neurologie

Dole, , France

Site Status

Hopital Victor Jousselin; Rhumatologie 4EME Sud

Druex, , France

Site Status

Hopital Sud; Rhumatologie

Échirolles, , France

Site Status

Chi Alpes Du Sud Site De Gap; Med Interne Et Polyvalente

Gap, , France

Site Status

Cabinet Medical.

Haguenau, , France

Site Status

Cabinet Medical

Haguenau, , France

Site Status

Cabinet medical; Rhumatologie

Joué-lès-Tours, , France

Site Status

CH de Juvisy sur Orge; Consult. externes

Juvisy-sur-Orge, , France

Site Status

Cabinet

La Madeleine, , France

Site Status

Hopital La Source; Rhumatologie

La Source, , France

Site Status

Ch De Laon; Medecine Interne

Laon, , France

Site Status

Ch Louis Pasteur; Medecine B3

Le Coudray, , France

Site Status

CH de Bicêtre; Rhumatologie

Le Kremlin-Bicêtre, , France

Site Status

Hopital Emile Roux; Rhumatologie

Le Puy-en-Velay, , France

Site Status

Hopital B Roger Salengro; Rhumatologie

Lille, , France

Site Status

Cabinet medical.

Lille, , France

Site Status

Hopital Dupuytren; Rhumatologie

Limoges, , France

Site Status

Cabinet de Rhumatologie MSP de Beaublanc

Limoges, , France

Site Status

Ctre De Rhumato Lyon Presqu ile

Lyon, , France

Site Status

Hopital Edouard Herriot; Pavillon F Rhumatologie

Lyon, , France

Site Status

Hopital Sainte Marguerite; Rhumatologie

Marseille, , France

Site Status

Fondation Hopital Saint Joseph; Rhumatologie

Marseille, , France

Site Status

CH Annecy Genevois; Rhumatologie

Metz-Tessy, , France

Site Status

GHI Le Raincy Montfermeil

Montfermeil, , France

Site Status

Cabinet medical; Cabinet medical

Montpellier, , France

Site Status

Cabinet Medical

Montpellier, , France

Site Status

Hopital Lapeyronie; Immunologie Rhumatologie

Montpellier, , France

Site Status

Hôpital Lapeyronie; Immuno-Rhumatologie Pr Jorgensen

Montpellier, , France

Site Status

Ch Des Pays De Morlaix; Medecine I

Morlaix, , France

Site Status

Cabinet Medical

Nice, , France

Site Status

Hopital Pasteur; Rhumatologie

Nice, , France

Site Status

Maison de Santé; MSP

Nogent-le-Rotrou, , France

Site Status

Ch Pitie Salpetriere; Rhumatologie

Paris, , France

Site Status

Hopital De La Croix Saint Simon; Medecine Interne Rhumatologie

Paris, , France

Site Status

Ch Lyon Sud; Rhumato Secteur Jules Courmont

Pierre-Bénite, , France

Site Status

Cabinet

Poitiers, , France

Site Status

Chu La Miletrie; Rhumatologie

Poitiers, , France

Site Status

Hopital Sud Anne de Bretagne; Rhumatologie

Rennes, , France

Site Status

Hôpital Victor Provo

Roubaix, , France

Site Status

Centre Medico-Chirurgical de Touraine

Saint-Cyr-sur-Loire, , France

Site Status

Cabinet Medical

Saint-Lô, , France

Site Status

Hopital Instruction Armees Begin; Rhumatologie

Saint-Mandé, , France

Site Status

Centre Hopsitalier Saint Nazaire; Medecine Polyvalente

Saint-Nazaire, , France

Site Status

Hopital Nord; Rhumatologie

Saint-Priest-en-Jarez, , France

Site Status

Centre Hospitalier Saint Quentin

Saint-Quentin, , France

Site Status

CH de Saint Quentin

Saint-Quentin, , France

Site Status

Centre medical des coteaux; Rhumatologie

Saintes, , France

Site Status

Hopital Hautepierre; Rhumatologie

Strasbourg, , France

Site Status

Hopitaux du Leman site Thonon; Rhumatologie

Thonon-les-Bains, , France

Site Status

Cabinet de Rhumatologie

Toulouse, , France

Site Status

Hopital Purpan; Rhumatologie

Toulouse, , France

Site Status

Cabinet Medical

Tours, , France

Site Status

Cabinet Medical

Valenciennes, , France

Site Status

Hopitaux De Brabois; Rhumatologie

Vandœuvre-lès-Nancy, , France

Site Status

Hopital; Pole geriatrique

Villeneuve-sur-Lot, , France

Site Status

Countries

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France

References

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Hilliquin P, Barnetche T, Baillet A, Flipo RM, Lespessailles E, Roux C, Fardellone P, Gilbert-Marceau A, Idier I, Constantin A, Shipley E, Baudens G, Saraux A. Real-World 1-Year Retention Rate of Subcutaneous Tocilizumab Treatment in Patients with Moderate to Severe Active Rheumatoid Arthritis: TANDEM Study. Rheumatol Ther. 2021 Mar;8(1):95-108. doi: 10.1007/s40744-020-00253-0. Epub 2020 Nov 20.

Reference Type DERIVED
PMID: 33216287 (View on PubMed)

Other Identifiers

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ML29256

Identifier Type: -

Identifier Source: org_study_id

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